Method and apparatus for impeding migration of an implanted occlusive structure

• US 8,968,353 B2
• Filed: 07/01/2011
• Issued: 03/03/2015
• Est. Priority Date: 01/25/2005
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Prestezog, Anna G., Mirizzi, Michael S., Karabey, Halil I., Rodriguez, John W., Thompson, Russell B.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/175,738
• Publication Number:
  US 20120029557A1
• Time in Patent Office: 1,341 Days
• Field of Search: 606/1, 606/139, 606/151, 606157-158, 606/191, 606/198, 606/200, 623/1.1, 623/1.11, 623/11.11, 623 1311- 132, 60416703-16706, 128/831, 424/423
• US Class Current: 606/200
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

A method of treating a hollow anatomical structure of a patient comprises implanting a bioabsorbable fibrous body in a hollow anatomical structure. The body is secured in the hollow anatomical structure to limit migration of the body within the hollow anatomical structure.

Claims

1. Apparatus for delivering an occlusive implant to a treatment site within a hollow anatomical structure (HAS), the apparatus comprising:

an elongate, flexible outer sheath defining an internal lumen and including a distal opening;

the occlusive implant within the lumen of the outer sheath, the implant comprising a fibrous mass structure including a plurality of loosely arranged fibers;

a delivery member configured to be axially reciprocated within the lumen of the outer sheath and extending through at least a portion of the implant, such that the implant occupies a space between the delivery member and the outer sheath, the delivery member including an elongate shaft and a forked distal tip; and

a handle connected to the outer sheath and the delivery member, the handle being actuable to reciprocate the delivery member relative to the outer sheath;

wherein the forked distal tip of the delivery member engages a distal end of the implant, and is configured such that when the delivery member is actuated forward, the forked distal tip extends distally beyond the distal opening of the outer sheath and expels the distal end of the implant from the outer sheath through the distal opening, and when the delivery member is subsequently retracted it disengages the distal end of the implant and reenters the outer sheath through the distal opening, and when the delivery member is subsequently actuated forward, it again engages the implant at a location along a length of the implant proximal of the distal end of the implant and expels more of the implant from the outer sheath through the distal opening.

2. The apparatus of claim 1, wherein the delivery member is configured to push the implant distally through the lumen of the outer sheath when the delivery member moves distally with respect to the outer sheath, and to withdraw proximally through the implant with little or no proximal movement of the implant with respect to the outer sheath when the delivery member moves proximally with respect to the outer sheath.

3. The apparatus of claim 1, wherein the elongate shaft of the delivery member comprises a material and construction with a sufficient column strength to push the implant distally within the lumen, but also sufficiently flexible to allow the apparatus to be navigated through a patient'"'"'s vasculature to the treatment site.

4. The apparatus of claim 1, wherein the forked distal tip of the delivery member comprises a plurality of hinged legs configured to pivot between a first open position, and a second closed position.

5. The apparatus of claim 4, wherein the legs are biased toward the first open position by a resilient biasing member that applies a biasing force to the legs.

6. The apparatus of claim 5, wherein the biasing force is sufficiently small that the legs deflect towards the second closed position as the delivery member moves proximally relative to the implant.

7. The apparatus of claim 4, further comprising a manual actuation member configured to move the legs between the first open position and the second closed position.

8. Apparatus for delivering an occlusive implant to a treatment site within a hollow anatomical structure (HAS), the apparatus comprising:

an elongate, flexible outer sheath defining an internal lumen and including a distal opening;

the occlusive implant within the lumen of the outer sheath, the implant comprising a fibrous mass structure including a plurality of loosely arranged fibers;

a delivery member configured to be axially reciprocated within the lumen and extending through at least a portion of the implant, such that the implant occupies a space between the delivery member and the outer sheath; and

a handle connected to the outer sheath and the delivery member, the handle being actuable to reciprocate the delivery member relative to the outer sheath;

wherein the delivery member includes an elongate shaft with a forked distal tip, and the outer sheath includes a plurality of claws adjacent the distal opening, the claws converging in the proximal-to-distal direction, such that the delivery member is configured to incrementally eject portions of the implant through the distal opening of the outer sheath as the delivery member moves distally within the lumen of the outer sheath, and the claws resist proximal movement of the implant through the distal opening as the delivery member moves proximally within the lumen of the outer sheath; and

wherein when the delivery member moves distally it engages a distal end of the implant, and when the delivery member subsequently moves proximally, and then again distally, it engages the implant at a location along a length of the implant proximal of the distal end of the implant.

9. The apparatus of claim 8, wherein the delivery member is configured to push the implant distally through the lumen of the outer sheath when the delivery member moves distally with respect to the outer sheath, and to withdraw proximally through the implant with little or no proximal movement of the implant with respect to the outer sheath when the delivery member moves proximally with respect to the outer sheath.

10. The apparatus of claim 8, wherein the elongate shaft of the delivery member comprises a material and construction with a sufficient column strength to push the implant distally within the lumen, but also sufficiently flexible to allow the apparatus to be navigated through a patient'"'"'s vasculature to the treatment site.

11. The apparatus of claim 8, wherein the claws are biased radially inwardly.

12. The apparatus of claim 8, wherein each claw tapers down to an apex defining a distal-most extent of each claw.